EPA's Section 18 approval time best ever

Environmental Protection Agency action on Section 18 emergency use exemptions for pesticides had the best turnaround time in the agency's history in the fiscal year just ended.

“The target has always been 50 days,” says Stephen Johnson, assistant administrator for the agency's Office of Prevention, Pesticides, and Toxic Substances. “But, when you're dealing with an emergency, even 50 days is too long.”

Prior to 2002, the average turnaround on Section 18 requests was 85 days.

“We worked long and hard to improve on that, and in fiscal 2002, our average turnaround was 33.3 days. We're really pleased that we've been able cut the time and still do a quality job,” he told members of the CropLife America and California Plant Health Association organizations at their combined annual meeting at Palm Desert, Calif.

It is hoped, Johnson said, that regulatory reform can make the process even more expeditious.

Proposals are being developed to revise Section 18 procedures, he said. “Ideally, after we do the initial first-year assessments, we'd like to give the states authority to grant Section 18s in years two, three, and four.”

There is “a lot of debate” over the issue of economic loss with regard to Section 18 determinations, Johnson said, and resolving that represents “a significantly high hurdle.” Resistance management is also a key consideration. “While there are provisions under Section 18 for resistance management, they are unclear, and there is room for improvement.”

In citing statistics for the EPA's accomplishments in the 2002 fiscal year, he said 26 new active ingredients were licensed; of those, 11 were biological materials, 12 were conventional, and three were microbials. In the group were four reduced risk pesticides, two that were jointly reviewed with Canada, and one that was parallel reviewed with Germany and the European Union.

Johnson said the EPA is continuing to try and resolve the dilemma of finances for its pesticide programs, which have “always been behind the 8-ball in terms of resources. We'd like to see this on a firm, stable financial footing.”

This may involve fees to the industry, he said, as a result of Food Quality Protection Act requirements, and “clearly federal tax dollar appropriations should play a role also — but how much remains to be determined.”

Another issue, he said, is thrashing out the issue of “chemicals that may not be pesticides.” For example, he noted that lindane is used more in shampoos that are regulated by the Food and Drug Administration than in pesticides regulated by the EPA.

“We don't want the EPA to wag the FDA's tail. It appears to be a conundrum for the EPA, and we haven't sorted out yet what's our job and what's the FDA's.”